Acute Metabolic Effects of Evolocumab and AtorvastatinEarly Phase 1NCT06140095
Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism
A Early Phase 1 study testing Evolocumab in people with Acute Metabolic Effects of Evolocumab and Atorvastatin, run by Region Stockholm.
Trial summary
Eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Metabolic Effects of Evolocumab and Atorvastatin
- What is being tested?
- Evolocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- >18 years of age
Who cannot join
- Cardiovascular disease
- Cerebrovascular disease (e.g. stroke, prior aneurysm)
- Pulmonary disease (e.g. pulmonary hypertension, COPD)
- Metabolic disease (incl. but not limited to Cushing disease, Diabetes)
- Renal disease (by Chronic kidney disease criteria)
- Active inflammatory bowel syndrome
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- Cancer
- Pregnancy
- Smoker
- Any chronic medication use
- Steroid treatment for the last six months or hormone replacement therapy
- Coagulopathy
- Musculoskeletal or neurologic disease
- Know allergy against any of the studied substances
Trial locations and contacts
No sites are listed yet.
Mats Eriksson, MD PhD contact
About this study
Eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism.
- Being tested
- Evolocumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
Also called Atorvastatin
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Full group | Experimental | Evolocumab 140 mg subcutaneously. Två months later, repetitive doses of atorvastatin 40 mg once daily.
After continued atorvastatin, evolocumab 140 mg is added subcutaneously. Receives: Drug: Evolocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol metabolism effect
Effect of these treatments on markers for cholesterol metabolism, namely lathosterol and campesterol, measured as change from baseline concentration (mg/mmol) per unit time.
Measured: 32 hours
Bile acid metabolism effect
Effect of these treatments on markers for bile acid metabolism, namely C4; measured as change from baseline concentration (mg/mmol) per unit time.
Measured: 32 hours
Bile acid metabolism effect
Effect of these treatments on markers for cholesterol and bile acid metabolism, namely bile acids; measured as change from baseline concentration (mikromol/ml) per unit time.
Measured: 32 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study startFeb 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Metabolic Effects of Evolocumab and AtorvastatinStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Amgen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140095
- Sponsor's protocol ID
- PSM1A
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism
- ClinicalTrials.gov ID
- NCT06140095
- Acronym / sponsor ID
- PSM1A
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Amgen
- Study start
- Feb 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full group | Experimental | Drug: EvolocumabEvolocumab 140 mg subcutaneously. Två months later, repetitive doses of atorvastatin 40 mg once daily. After continued atorvastatin, evolocumab 140 mg is added subcutaneously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male
- >18 years of age
Key exclusion criteria (14 listed)
- Cardiovascular disease
- Cerebrovascular disease (e.g. stroke, prior aneurysm)
- Pulmonary disease (e.g. pulmonary hypertension, COPD)
- Metabolic disease (incl. but not limited to Cushing disease, Diabetes)
- Renal disease (by Chronic kidney disease criteria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvolocumabAlso: AtorvastatinSee arm description | Drug | Full group |
Primary outcome
Cholesterol metabolism effect
Time frame: 32 hours
Effect of these treatments on markers for cholesterol metabolism, namely lathosterol and campesterol, measured as change from baseline concentration (mg/mmol) per unit time.
Bile acid metabolism effect
Time frame: 32 hours
Effect of these treatments on markers for bile acid metabolism, namely C4; measured as change from baseline concentration (mg/mmol) per unit time.
Bile acid metabolism effect
Time frame: 32 hours
Effect of these treatments on markers for cholesterol and bile acid metabolism, namely bile acids; measured as change from baseline concentration (mikromol/ml) per unit time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mats Eriksson, MD PhD contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Evolocumab in people with Acute Metabolic Effects of Evolocumab and Atorvastatin, run by Region Stockholm.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erik Hoffmann, MD (+46 8-517 700 00, erik.hoffmann@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cholesterol metabolism effect (time frame: 32 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.